FDA Enforcement
Class II
Terminated
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Recall: Z-0197-2019
·
Reported October 31, 2018
Enforcement
- Recall Number
- Z-0197-2019
- Event ID
- 81080
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shimadzu Medical Systems Usa Com
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 31, 2018
- Initiation Date
- June 15, 2018
- Classification Date
- October 19, 2018
- Termination Date
- April 28, 2021
- Address
- 20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States
Description
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Reason
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
Code Info
Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001
Distribution
Domestic: LA
Quantity
1